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Related Experiment Videos

Long-term safety of risperidone.

M Davidson1

  • 1Department of Psychiatry, Tel Aviv University, Israel.

The Journal of Clinical Psychiatry
|October 5, 2001
PubMed
Summary
This summary is machine-generated.

Risperidone at 1 mg/day showed similar adverse events to placebo in dementia patients. Long-term use revealed a very low incidence of tardive dyskinesia, indicating favorable safety and tolerability.

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Area of Science:

  • Geriatric Psychiatry
  • Pharmacology
  • Clinical Trials

Background:

  • Elderly dementia patients often exhibit behavioral and psychological symptoms.
  • Antipsychotic medications are frequently used, but safety concerns exist in this population.
  • Risperidone is an atypical antipsychotic used for various conditions.

Purpose of the Study:

  • To evaluate the safety and tolerability of risperidone in elderly patients with dementia.
  • To compare adverse events of risperidone versus placebo.
  • To assess the incidence of tardive dyskinesia during long-term risperidone treatment.

Main Methods:

  • Two pivotal randomized controlled trials comparing risperidone to placebo.
  • Open-label, 12-month extension studies.

Related Experiment Videos

  • Assessment of adverse events, vital signs, laboratory values, and incidence of tardive dyskinesia.

    • Main Results:

    • Adverse event risk was similar between risperidone (1 mg/day) and placebo groups.
    • The incidence of de novo tardive dyskinesia was very low during 12-month extensions.
    • No clinically significant adverse events, vital sign changes, or laboratory abnormalities were noted.

    Conclusions:

    • Risperidone at a dose of 1 mg/day is safe and well-tolerated in elderly dementia patients.
    • Long-term treatment with risperidone in this population is associated with a low risk of tardive dyskinesia.
    • The favorable safety profile supports the use of risperidone for managing dementia symptoms.